Regulatory

Unichem receives ANDA approval for quetiapine extended-release tablets

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)

  • By IPP Bureau | August 16, 2022

Unichem Laboratories Limited has received ANDA approval for its Quetiapine Extended-Release Tablets USP, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg from the United States Food and Drug Administration (USFDA) to market a generic version of SEROQUEL XR® (Quetiapine) Tablet, Extended Release, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg of AstraZeneca Pharmaceuticals LP.

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD). The product will be commercialized from Unichem's Goa Plant.

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